Progestagens for the Tertiary Prophylaxis of Preterm Delivery
NCT ID: NCT01178788
Last Updated: 2016-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
254 participants
INTERVENTIONAL
2010-02-28
2015-12-31
Brief Summary
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Main outcome: Delivery before 37 weeks.
Secondary outcomes: Gestational age at delivery, Delivery \<32, \<35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies.
Allocated treatments will be:
Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation
Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded.
Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting.
Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients.
Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.
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Detailed Description
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Protocol: Women will be treated with P, 17P or just clinically observed according to on-line randomization assignment provided by the Methodological Unit. Treatments end at the completion of 36th week. Randomization will be stratified for early (22-27+6th) and late (28-31+6th wks) PTD risk. Interim analysis will be done at 50% enrollment.
Sixty women will be allocated to each Clinical Centre to reach 480 enrollments, in the 3 arms.
Drugs will be provided by manufacturers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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17 alfa hydroxy Progesterone caproate
Women treated with i.m. 17P injection/weekly (Lentogest, IBSA, Italy)
17 alpha-hydroxy progesterone caproate
weekly injection of 17 P
Micronized Progesterone
micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium)
micronized Progesterone
daily administration of vaginal progesterone
Control
Routine clinical controls
Control
Interventions
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17 alpha-hydroxy progesterone caproate
weekly injection of 17 P
micronized Progesterone
daily administration of vaginal progesterone
Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Prof. Facchinetti Fabio
Chairman of Obstetric-Gynecology Unit
Principal Investigators
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Fabio Facchinetti, M.D.
Role: STUDY_CHAIR
University of Modena and Reggio Emilia
Locations
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University of Modena and Reggio Emilia
Modena, , Italy
Countries
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References
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Facchinetti F, Vergani P, Di Tommaso M, Marozio L, Acaia B, Vicini R, Pignatti L, Locatelli A, Spitaleri M, Benedetto C, Zaina B, D'Amico R. Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):64-70. doi: 10.1097/AOG.0000000000002065.
Other Identifiers
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2009-017441-63
Identifier Type: -
Identifier Source: org_study_id
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